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一项研究如何将 Avacincaptad Pegol (Izervay™) 用于地理萎缩患者的临床实践

2026年10月26日 更新者：Astellas Pharma Global Development, Inc.

一项非介入性观察性研究，旨在评估 Avacincaptad Pegol (ACP/IZERVAY™) 在继发于年龄相关性黄斑变性的地图样萎缩患者的常规临床实践中的治疗模式和安全性

This study is for people who have geographic atrophy due to age-related macular degeneration (AMD). AMD happens when the macula, the light-sensitive layer at the back of the eye called the retina, becomes damaged and causes a person's central vision to worsen. Geographic atrophy is an advanced form of AMD where cells in the retina waste away and die. Over time this can lead to permanent loss of vision.

Avacincaptad pegol can help slow down the worsening or progression of geographic atrophy. Avacincaptad pegol is a treatment approved in the US to treat geographic atrophy.

This study is about collecting information on how people with geographic atrophy are treated in routine clinical practice. This includes recording any medical problems from avacincaptad pegol. This is known as an observational study. Information will be collected from the peoples' medical records during and after treatment. The people in this study will have geographic atrophy in 1 or both eyes and they and their doctor have decided they will be treated with avacincaptad pegol. The individual's doctor decides on treatment, not the study sponsor (Astellas).

People that want to take part in the study will have eye examinations that they would usually have as part of their routine care. People will also be asked to complete surveys about their eye health. These surveys will occur when treatment starts and then every 6 months for the first 2 years. After 2 years the surveys will happen once a year. The people on the study can take part if their doctor provides treatment with avacincaptad pegol and they want to continue with the study. The people on the study can take part for around 5 years.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

观察性的

注册 (实际的)

488

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85053
        • Retinal Consultants of AZ
      • Scottsdale、Arizona、美国、85255
        • Retina Macula Institute of Arizona
    • California
      • Laguna Hills、California、美国、92653
        • Harvard Eye Associates
      • Orange、California、美国、92868
        • University of California Irvine Medical Center
      • Redlands、California、美国、92374
        • Retina Consultants of Southern CA
      • Sacramento、California、美国、95825
        • Retinal Consultants Medical Group Inc
      • Torrance、California、美国、90503
        • Retina Macula Institute
    • Colorado
      • Aurora、Colorado、美国、80045
        • Rocky Mountain Lions Eye Institute
      • Colorado Springs、Colorado、美国、80909
        • Retina Consultants of Southern Colorado
      • Lakewood、Colorado、美国、80228
        • Colorado Retina Associates, PLLC
    • Connecticut
      • Greenwich、Connecticut、美国、05830
        • Coastal Eye Surgeons
    • Florida
      • Bonita Springs、Florida、美国、34134
        • Advanced Retina Institute
      • Coral Gables、Florida、美国、33146
        • University of Miami
      • Palm Beach Gardens、Florida、美国、33410
        • Retina Care Specialists
      • Tampa、Florida、美国、33606
        • Eye Physicians of Pinellas PA dba Eye Institute of West Florida
      • Wesley Chapel、Florida、美国、33544
        • Retina Specialists of Tampa
    • Georgia
      • Augusta、Georgia、美国、30909
        • Southeast Retina Center, P.C.
    • Illinois
      • Oak Forest、Illinois、美国、60452
        • University Retina and Macula Associates, P.C.
      • Oak Park、Illinois、美国、60304
        • Illinois Retina Associates
      • Peoria、Illinois、美国、61615
        • Illinois Eye Center
    • Iowa
      • West Des Moines、Iowa、美国、50266
        • Wolfe Eye Clinic
    • Maryland
      • Hagerstown、Maryland、美国、21740
        • Cumberland Valley Retina Consultants,P.C.
    • Michigan
      • Grand Blanc、Michigan、美国、48439
        • Retina Associates of Michigan
    • Minnesota
      • Saint Louis Park、Minnesota、美国、55416
        • Retina Consultants of Minnesota PLLC
    • Mississippi
      • Madison、Mississippi、美国、39110
        • Mississippi Retina Associates
      • Olive Branch、Mississippi、美国、38654
        • Brown Family Retina PLLC
      • Southaven、Mississippi、美国、38671
        • Deep Blue Retina Clinical Research
    • Nevada
      • Reno、Nevada、美国、89502
        • Sierra Eye Associates
    • New Jersey
      • Dover、New Jersey、美国、07801
        • Eye Associates of North Jersey PA
      • Edison、New Jersey、美国、08820
        • NJ Retina
      • Lakewood、New Jersey、美国、08701
        • NJ Retina
      • Toms River、New Jersey、美国、08755
        • NJ Retina
    • New York
      • Brentwood、New York、美国、11717
        • SightMD
      • Liverpool、New York、美国、13088
        • Retina-Vitreous Surgeons of Central NY
      • Massapequa、New York、美国、11758
        • NY Retina Ophthalmology PLLC
      • New York、New York、美国、10075
        • Retina Associates of New York
      • Scarsdale、New York、美国、10583
        • Long Island Vitreoretinal Consultants
      • Shirley、New York、美国、11967
        • Vitreoretinal Consultants
    • North Carolina
      • Wake Forest、North Carolina、美国、27587
        • North Carolina Retina Associates
    • Ohio
      • Columbus、Ohio、美国、43221
        • The Ohio State University
      • Dayton、Ohio、美国、45459
        • CEI Physicians PSC, LLC dba
    • Oregon
      • Eugene、Oregon、美国、97401
        • Verum Research, LLC
    • Pennsylvania
      • Erie、Pennsylvania、美国、16507
        • Erie Retina Research
    • Tennessee
      • Knoxville、Tennessee、美国、37920
        • Southeastern Retina Associates, P.C.
      • Knoxville、Tennessee、美国、37923
        • Southeastern Retina Associates, P.C.
      • Memphis、Tennessee、美国、38119
        • Mid South Retina Associates
      • Nashville、Tennessee、美国、37203
        • Tennessee Retina, PC
    • Texas
      • Abilene、Texas、美国、79606
        • Retina Research Institute of Texas
      • Dallas、Texas、美国、75243
        • Retina of North Texas
      • McAllen、Texas、美国、78503
        • Valley Retina Institute
      • San Antonio、Texas、美国、78240
        • Medical Center Ophthalmology Associates
      • San Antonio、Texas、美国、78240
        • Retina Associates Of South Texas, Pa
    • Utah
      • Murray、Utah、美国、84107
        • Retina Associates of Utah, P.C.
      • Salt Lake City、Utah、美国、84120
        • Salt Lake Retina
    • Virginia
      • Fairfax、Virginia、美国、22031
        • The Retina Group of Washington
      • Lynchburg、Virginia、美国、24502
        • Piedmont Eye Center, Inc.
      • Warrenton、Virginia、美国、20186
        • Virginia Retina Center
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Retina & Vitreous Consultants of Wisconsin

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Participants from both academic and non-academic sites, urban and rural across the US to ensure a heterogenous population that is representative of the US GA secondary to AMD population and reflective of real-world practice patterns.

描述

Inclusion Criteria:

  • Patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in 1 or both eyes
  • Patient with a decision to treat with intravitreal avacincaptad pegol (ACP) prior to enrollment
  • Patient willingness to complete the patient reported outcome (PRO).

Exclusion Criteria:

  • Patients who have any contraindication or are not eligible for treatment with ACP, including the following:

    • Active ocular or peri-ocular infection in either eye
    • Active, suspected intraocular inflammation in either eye
    • Hypersensitive to ACP or to any ingredient in the formulation

  • Patients currently participating in an investigational program with interventions outside of routine clinical practice.

  • Patients who have received ACP in the eye being considered for enrollment. Note: Patients who have received or are receiving ACP in the fellow eye at baseline are eligible to be included in the study.

  • Patients who have received any intravitreal complement inhibitor other than ACP in either eye. Note: Patients who have received an intravitreal complement inhibitor other than ACP in either eye and have completed the 90-day washout period are eligible to be included in the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Izervay

Patients with geographic atrophy (GA) secondary to AMD who have made decision to begin treatment with Izervay
药品：Avacincaptad pegol (ACP)

intravitreal injection

其他名称：
  • 伊泽维™

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of ACP injections
大体时间：Up to 61 Months

The number of ACP injections.
Up to 61 Months
Duration of treatment
大体时间：Up to 61 Months

The duration of treatment will be calculated as the difference between the date of the last injection and the date of the first injection plus 31 days (as the next injection would be expected at least 30 days after the last one).
Up to 61 Months
Annual frequency of ACP injection
大体时间：Up to 61 Months

The annual frequency of ACP injections will be calculated as the total number of injections divided by the treatment duration in years.
Up to 61 Months
Reasons for discontinuation of treatment with ACP
大体时间：Up to 61 Months

The reasons for discontinuation of treatment with ACP will be recorded.
Up to 61 Months
Duration of the treatment interval
大体时间：Up to 61 Months

The treatment interval is defined as mean number of days between injections, if a study eye receives more than 1 injection.
Up to 61 Months
Site characteristics
大体时间：Day 1

Characteristics of interest will be recorded including the type of setting (e.g., public/private facility, rural/urban).
Day 1
Characteristics of patients with geographic atrophy (GA) secondary to AMD beginning treatment with Izervay
大体时间：Day 1

Characteristics of interest will be recorded.
Day 1

次要结果测量

结果测量
措施说明
大体时间
Number of participants with Adverse Events (AEs)
大体时间：Up to 61 Months

An AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment.

An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal (investigational) product.
Up to 61 Months
Number of participants with Serious Adverse Events (SAEs)
大体时间：Up to 61 Months

An SAE is defined as an AE that results in death, is life-threatening, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization or other medically important events.
Up to 61 Months
Number of participants with Treatment Emergent Adverse Events (TEAEs)
大体时间：Up to 61 Months

TEAE is defined an AE observed after starting administration of the study drug and will continue until 30 days after the last administration or until last study visit, whichever is sooner.
Up to 61 Months
Number of participants with Adverse Event of Special Interest (AESI)
大体时间：Up to 61 Months

AESIs are defined as the following AEs:

  • Endophthalmitis
  • choroidal neovascularization (CNV)
  • Intraocular inflammation (including retinal vasculitis)
  • Increased intraocular pressure (IOP) ≥ 30 mmHg at 30 minutes post injection deemed clinically significant by the investigator
  • Elevation of IOP post injection requiring surgical/procedural intervention
  • Ischemic optic neuropathy
Up to 61 Months
Number of Participants maintaining vision
大体时间：Up to 61 Months

Maintaining vision is defined as not losing ≥ 15 letters on Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Up to 61 Months
Time to vision loss using various thresholds
大体时间：Up to 61 Months

Time to vision loss is defined as the difference between the date when vision loss was reported for the first time and the start date of treatment.
Up to 61 Months
Time to thresholds associated with ability to drive
大体时间：Up to 61 Months

Time to thresholds associated with the ability to drive will be based on visual acuity data captured as per standard of care.
Up to 61 Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Astellas Pharma Global Development, Inc.

调查人员

  • 研究主任：Medical Director、Astellas Pharma Global Development, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年1月22日

初级完成 (估计的)

2030年10月31日

研究完成 (估计的)

2030年10月31日

研究注册日期

首次提交

2024年12月16日

首先提交符合 QC 标准的

2025年1月13日

首次发布 (实际的)

2025年1月17日

研究记录更新

最后更新发布 (实际的)

2026年10月27日

上次提交的符合 QC 标准的更新

2026年10月26日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 3021-MA-3543

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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